MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-880010
Medical Device Problem Codes	Premature Activation (1484); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gda embolization.A femoral access via 6f sheath, 5f base catheter used and a 2.4fx110cm progreat and 016 gwgt to access celiac to gda.Some kickback was observed with catheter maintaining support into the celiac trunk throughout the case.Deployed two 018cx coils first to create a back stop and had no issues.Deployed a 10cm hydropack with no issue.Went to deploy the second 10cm hydropack and the black stopper got stuck in the hoop and caused the coil introducer sheath to stay in the hoop.When the tech was finally able to get the coil out of the hoop, the tech felt some resistance.The physician and i both examined the coil on the back table and decided not to use in the patient because we were concerned about potential stretching to the connection polymer and the coil body itself.A second 10cm hydropack was pulled.No issues removing from the hoop.As the physician was advancing this hydropack through the progreat it self-detached.The physician was able to contain it within the progreat, remove the microcatheter entirely from the body and safely remove the coil from the microcatheter.Unfortunately, the coil was hanging out of the progreat slightly and encountered resistance as it was coming out of the hub of the base catheter.When the physician pushed the coil out of the progreat on the back table, it had broken into two parts.A fresh progreat was used to reaccess the gda.Because we were out of 10cm hydropacks, a 5cm hydropack was successfully placed instead.Another two 018cx coils were used to cap off the vessel and stasis was achieved.The physician was happy with the result and was able to close with angioseal.The patient was stable and in the recovery unit.No injury to the patient.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

• Brand Name: HP8 AZUR HYDROPACK 18
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 25075363
• Report Number: 2032493-2026-00299
• Device Sequence Number: 16041787
• Product Code: KRD
• UDI-Device Identifier: 00842429118047
• UDI-Public: (01)00842429118047(11)241122(17)291031(10)0000780998
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-880010
• Device Lot Number: 0000780998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown